ODAC Recommends Approval of Three Agents

Thursday, July 1, 1999

Volume:

8

Issue:

7

SILVER SPRING, MdThe Oncologic Drugs Advisory Committee
(ODAC) recommended at its most recent meeting that the Food and Drug
Administration approve one new anticancer agent and additional
indications for two available agents. Complete reports on the
panels three recommendations will appear in the next issue of Oncology
News International.

The panel urged:

Marketing approval for Ellence (epirubicin hydrochloride for
injection, Pharmacia & Upjohn) for use as a component of adjuvant
therapy in patients with evidence of axillary node tumor involvement
following resection of primary breast cancer (stage II and III).

The panel, however, refused to recommend Ellences approval as a
therapy for patients with locally advanced or metastatic breast
cancer. Epirubicin, marketed elsewhere as Farmorubicin, was first
approved in France in 1982 and is now registered in 80 countries.

Accelerated approval of a supplemental New Drug Application for Doxil
(doxorubicin HCl liposome injection, Alza) for the treatment of
patients with metastatic carcinoma of the ovary who are refractory to
both paclitaxel (Taxol)- and platinum-based chemotherapy regimens.
Refractory was defined as progressive disease while on treatment or
within 6 months after completing therapy. Accelerated approval
requires the company to conduct additional research to ensure that
the drug is safe and effective.

Approval of a supplemental New Drug Application for Ethyol
(amifostine for injection, US Bioscience) to decrease the incidence
of moderate-to-severe xerostomia in patients undergoing postoperative
radiation therapy for head and neck cancer, where the radiation port
includes a substantial portion of the parotid glands.

(As Oncology News International went to press, the FDA granted
approval for this new Ethyol indication. Ethyol is the first
pharmaceutical product to receive approval to reduce the severity of
radiation-induced toxicities in head and neck cancer patients.